ENZYNATIC TRIGLYCERIDES REAGENT SET
Device Facts
| Record ID | K855164 |
|---|---|
| Device Name | ENZYNATIC TRIGLYCERIDES REAGENT SET |
| Applicant | Sterling Diagnostics, Inc. |
| Product Code | CDT · Clinical Chemistry |
| Decision Date | Feb 19, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1705 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
